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2012 ACCF/AHA/ACP/AATS/PCNA/SCAI/STS Guideline for the diagnosis and management of patients with stable ischemic heart disease: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines, and the American College of Physicians, American Association for Thoracic Surgery, Preventive Cardiovascular Nurses Association, Society for Cardiovascular Angiography and Interventions, and Society of Thoracic Surgeons Relation of Stature to Outcomes in Korean Patients Undergoing Primary Percutaneous Coronary Intervention for Acute ST-Elevation Myocardial Infarction (from the INTERSTELLAR Registry) Complete revascularisation versus treatment of the culprit lesion only in patients with ST-segment elevation myocardial infarction and multivessel disease (DANAMI-3—PRIMULTI): an open-label, randomised controlled trial Decade-Long Trends (2001 to 2011) in the Use of Evidence-Based Medical Therapies at the Time of Hospital Discharge for Patients Surviving Acute Myocardial Aspirin-Free Prasugrel Monotherapy Following Coronary Artery Stenting in Patients With Stable CAD: The ASET Pilot Study Mechanisms of Vascular Aging, A Geroscience Perspective JACC Focus Seminar Antithrombotic Therapy after Acute Coronary Syndrome or PCI in Atrial Fibrillation Analysis of reperfusion time trends in patients with ST-elevation myocardial infarction across New York State from 2004 to 2012 Effect of Plaque Burden and Morphology on Myocardial Blood Flow and Fractional Flow Reserve Temporal trends in percutaneous coronary interventions thru the drug eluting stent era: Insights from 18,641 procedures performed over 12-year period

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Clinical TrialOctober 2020

JOURNAL：JACC Article Link

Percutaneous Coronary Intervention for Vulnerable Coronary Atherosclerotic Plaque

GW. Stone, A Maehara, and for the PROSPECT ABSORB Investigators. Keywords: vulnerable plaque; prognosis; stent; bioresorbable scaffold

ABSTRACT

BACKGROUND - Acute coronary syndromes most commonly arise from thrombosis of lipid-rich coronary atheromas that have large plaque burden despite angiographically appearing mild.

OBJECTIVES - We sought to examine the outcomes of percutaneous coronary intervention (PCI) of non-flow-limiting vulnerable plaques.

METHODS - Three-vessel imaging was performed with a combination intravascular ultrasound (IVUS) and near-infrared spectroscopy (NIRS) catheter after successful PCI of all flow-limiting coronary lesions in 898 patients presenting with myocardial infarction (MI). Patients with an angiographically non-obstructive stenosis not intended for PCI but with IVUS plaque burden ≥65% were randomized to treatment of the lesion with a bioresorbable vascular scaffold (BVS) plus guideline-directed medical therapy (GDMT) vs. GDMT alone. The primary powered effectiveness endpoint was the IVUS-derived minimum lumen area (MLA) at protocol-driven 25-month follow-up. The primary (non-powered) safety endpoint was randomized target lesion failure (TLF; cardiac death, target vessel-related MI or clinically-driven target lesion revascularization) at 24 months. The secondary (non-powered) clinical effectiveness endpoint was randomized lesion-related major adverse cardiac events (MACE; cardiac death, MI, unstable angina, or progressive angina) at latest follow-up.

RESULTS - A total of 182 patients were randomized (93 BVS, 89 GDMT alone) at 15 centers. The median angiographic diameter stenosis of the randomized lesions was 41.6%; by NIRS-IVUS median plaque burden was 73.7%, median MLA was 2.9 mm², and median maximum lipid plaque content was 33.4%. Angiographic follow-up at 25 months was completed in 167 patients (91.8%), and median clinical follow-up was 4.1 years. The follow-up MLA in BVS-treated lesions was 6.9±2.6 mm² compared with 3.0±1.0 mm² in GDMT alone-treated lesions (least square means difference 3.9 mm², 95% CI 3.3-4.5, P<0.0001). TLF at 24 months occurred in similar rates of BVS-treated and GDMT alone-treated patients (4.3% vs. 4.5%; P=0.96). Randomized lesion-related MACE occurred in 4.3% BVS-treated patients vs. 10.7% GDMT alone-treated patients (OR 0.38, 95% CI 0.11-1.28, P=0.12).

CONCLUSIONS - PCI of angiographically mild lesions with large plaque burden was safe, substantially enlarged the follow-up MLA and was associated with favorable long-term clinical outcomes, warranting the performance of an adequately powered randomized trial.

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Percutaneous Coronary Intervention for Vulnerable Coronary Atherosclerotic Plaque

ABSTRACT